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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, shoulder, non-constrained, metal/polymer cemented
Product CodeKWT
Regulation Number 888.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 421 421
2020 216 216
2021 228 228
2022 275 275
2023 384 384
2024 229 229

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 620 620
Device Dislodged or Dislocated 302 302
Loosening of Implant Not Related to Bone-Ingrowth 186 186
Fracture 162 162
Break 91 91
Detachment of Device or Device Component 86 86
Appropriate Term/Code Not Available 84 84
Insufficient Information 62 62
Naturally Worn 56 56
Loose or Intermittent Connection 44 44
Unstable 28 28
Patient Device Interaction Problem 18 18
Migration 11 11
Physical Resistance/Sticking 10 10
Patient-Device Incompatibility 10 10
Inadequacy of Device Shape and/or Size 10 10
Material Erosion 10 10
Loss of or Failure to Bond 10 10
Improper or Incorrect Procedure or Method 7 7
Difficult to Insert 7 7
Positioning Problem 7 7
Unintended Movement 7 7
Malposition of Device 6 6
Difficult to Remove 6 6
Material Separation 6 6
Mechanical Problem 6 6
Migration or Expulsion of Device 5 5
Loss of Osseointegration 5 5
Device Slipped 4 4
Mechanical Jam 4 4
Activation, Positioning or Separation Problem 3 3
Contamination /Decontamination Problem 3 3
Misassembly by Users 3 3
Therapeutic or Diagnostic Output Failure 3 3
Noise, Audible 3 3
Defective Device 3 3
Microbial Contamination of Device 3 3
Disconnection 3 3
Entrapment of Device 2 2
Material Fragmentation 2 2
Component Missing 2 2
Fitting Problem 2 2
Off-Label Use 2 2
Separation Problem 2 2
Biocompatibility 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Inaccurate Information 2 2
Measurement System Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Output Problem 1 1
Connection Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Difficult or Delayed Separation 1 1
Device Fell 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
No Apparent Adverse Event 1 1
Material Puncture/Hole 1 1
Device Appears to Trigger Rejection 1 1
Dull, Blunt 1 1
Failure to Align 1 1
Failure to Advance 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Material Frayed 1 1
Misassembled 1 1
Material Disintegration 1 1
Device Alarm System 1 1
Corroded 1 1
Degraded 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 583 583
Joint Dislocation 231 231
Bacterial Infection 177 177
Pain 156 156
Unspecified Infection 119 119
Bone Fracture(s) 109 109
No Known Impact Or Consequence To Patient 79 79
No Code Available 78 78
No Clinical Signs, Symptoms or Conditions 58 58
Insufficient Information 54 54
No Information 43 43
No Consequences Or Impact To Patient 31 31
Loss of Range of Motion 26 26
Muscle/Tendon Damage 23 23
Device Embedded In Tissue or Plaque 19 19
Fall 18 18
Osteolysis 15 15
Joint Laxity 15 15
Limited Mobility Of The Implanted Joint 12 12
Erosion 12 12
Wound Dehiscence 11 11
Necrosis 10 10
Tissue Damage 10 10
Injury 9 9
Inadequate Osseointegration 9 9
Osteopenia/ Osteoporosis 9 9
Implant Pain 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Impaired Healing 8 8
Unspecified Tissue Injury 7 7
Foreign Body In Patient 7 7
Post Operative Wound Infection 6 6
Ossification 6 6
Hematoma 5 5
Joint Disorder 5 5
Swelling/ Edema 5 5
Non-union Bone Fracture 4 4
Reaction 4 4
Numbness 4 4
Patient Problem/Medical Problem 4 4
Subluxation 4 4
Pneumothorax 4 4
Urinary Retention 3 3
Inflammation 3 3
Erythema 3 3
Unspecified Musculoskeletal problem 3 3
Metal Related Pathology 3 3
Arthralgia 3 3
Blood Loss 3 3
No Patient Involvement 2 2
Tissue Breakdown 2 2
Cognitive Changes 2 2
Purulent Discharge 2 2
Connective Tissue Disease 2 2
Anemia 2 2
Arthritis 2 2
Local Reaction 2 2
Swelling 2 2
Nerve Damage 2 2
Hypersensitivity/Allergic reaction 1 1
Tingling 1 1
Fracture, Arm 1 1
Discharge 1 1
Excessive Tear Production 1 1
Discomfort 1 1
Toxicity 1 1
Adhesion(s) 1 1
Radiation Burn 1 1
Calcium Deposits/Calcification 1 1
Stroke/CVA 1 1
Debris, Bone Shedding 1 1
Muscular Rigidity 1 1
Constipation 1 1
Not Applicable 1 1
Muscle Hypotonia 1 1
Malunion of Bone 1 1
Decreased Sensitivity 1 1
Ambulation Difficulties 1 1
Reaction to Medicinal Component of Device 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jan-18-2024
2 Zimmer Biomet, Inc. II Nov-07-2019
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